Tacrolimus Ointment 0.03%
37 adverse event reports submitted to the FDA
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
37
Total Reports
2
Deaths Reported
540.0%
Death Rate
Active Ingredients
Tacrolimus Ointment 0.03%
Administration Routes
UnknownOphthalmicIntraocularTopicalAuricular (Otic)
Species Affected
Dog 37
Most Affected Breeds
Spaniel - Cocker American 4
Bulldog 4
Shih Tzu 3
Shepherd Dog - German 3
Spaniel - King Charles Cavalier 3
Crossbred Canine/dog 2
Sheepdog - Shetland 2
Pug 2
Terrier - West Highland White 2
Terrier - Scottish 1
Most Reported Reactions
Emesis 14
Vomiting 6
Lethargy (see also Central nervous system depression in 'Neurological') 5
Lack of efficacy - NOS 5
Lack of efficacy (endoparasite) - hookworm 3
Weight loss 2
Ataxia 2
Weakness 2
Loose stool 2
Itching 2
Not eating 2
Panting 2
Outcome Breakdown
Recovered/Normal
20 (54.1%)
Recovered with Sequela
7 (18.9%)
Ongoing
4 (10.8%)
Outcome Unknown
4 (10.8%)
Died
1 (2.7%)
Euthanized
1 (2.7%)
Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.